在患有活性类风湿性关节炎的患者中,在生物类似的阿达利穆马布PF-06410293和参考阿达利穆马布之间进行多次切换:一个第三阶段,开放标签,随机化,并行组研究
Roy M Fleischmann1, Wassim Saikali2, Sharad Lakhanpal3
1University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX, USA.
The Lancet. Rheumatology
|January 22, 2024
概括
亚达利穆马布生物仿制品PF-06410293 (adalimumab-afzb) 已证明可以与参考亚达利穆马布进行互换. 与单独使用参考阿达利木马布相比,在两者之间进行多次切换并没有显示有效性或安全性下降.
科学领域:
- 类风湿病学 类风湿病学
- 药理动力学 药理动力学
- 免疫性 免疫性 免疫性
背景情况:
- 阿达利穆马布生物相似物互换性可以改善患者获得有效治疗的机会.
- 评估阿达利穆马布-afzb与参考阿达利穆马布的可互换性至关重要.
研究的目的:
- 评估阿达利穆马布生物类似物PF-06410293 (阿达利穆马布-afzb) 和参考阿达利穆马布的可互换性.
- 在多开关研究设计中评估疗效和安全结果.
主要方法:
- 这是一项开放标签,随机,并行组研究,在10个国家的61个地点进行.
- 接受稳定的甲状腺素治疗的类风湿性关节炎患者随机被分配到阿达利木巴-afzb和参考阿达利木巴之间切换或持续参考阿达利木巴剂量.
- 主要终点包括在30-32周内观察到的最大血清度 (Cmax) 和血度-时间曲线下的面积 (AUCτ).
主要成果:
- 切换和非切换组之间的药理动力学参数 (AUCτ和Cmax) 是可比的,几何平均比在80-125%的等效率范围内.
- 在安全概况中没有观察到临床上有意义的差异,包括严重不良事件,特别感兴趣的不良事件或免疫反应.
- 由于不良事件而出现不良事件或中止治疗的患者比例在各组之间相似.
结论:
- 与连续使用参考阿达利木巴相比,在参考阿达利木巴和阿达利木巴-afzb之间进行多次切换与有效性或安全性的降低无关.
- 阿达利穆马布-afzb是一种可互换的生物类似剂,用于参考阿达利穆马布.
相关概念视频
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
139
Tumor Necrosis Factor (TNF), a proinflammatory cytokine, contributes significantly to the inflammation seen in Crohn's disease. It exists as soluble TNF and membrane-bound TNF, with actions mediated through TNF receptors (TNFR). TNFR activation leads to the release of proinflammatory cytokines, T-cell activation, collagen production, and leukocyte migration, all contributing to inflammation in Crohn's disease. Anti-TNF monoclonal antibodies, namely infliximab (Remicade), adalimumab...
139
Bioequivalence: Overview
1.0K
Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
1.0K
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
166
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
166
Inflammatory Bowel Disease IV: Pharmacological Management
127
Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
Pharmacologic...
127


